Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Postoperative Anal… (NCT07605208) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Postoperative Analgesia After Total Knee Arthroplasty
Turkey (Türkiye)90 participantsStarted 2026-06-01
Plain-language summary
The goal of this clinical trial is to compare two different epidural analgesia delivery methods for pain control after total knee arthroplasty in adults undergoing elective surgery. The study will evaluate whether programmed intermittent epidural bolus (PIEB) provides better postoperative analgesia and recovery outcomes than continuous epidural infusion (CEI).
The main questions it aims to answer are:
Does PIEB reduce total epidural local anesthetic consumption during the first 24 postoperative hours compared with CEI? Does PIEB improve postoperative pain control and quality of recovery? Are there differences between the two methods regarding motor block, rescue analgesic requirement, patient-controlled epidural analgesia use, and adverse effects?
Researchers will compare PIEB plus patient-controlled epidural analgesia (PCEA) with CEI plus PCEA in patients undergoing total knee arthroplasty.
Participants will:
Receive combined spinal-epidural anesthesia during surgery Receive postoperative epidural analgesia using either PIEB or CEI Be evaluated for pain scores, motor block, recovery quality, epidural local anesthetic consumption, rescue analgesic requirement, and adverse events during the first 24 postoperative hours
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 to 80 years
* American Society of Anesthesiologists (ASA) physical status I-III
* Scheduled for elective primary total knee arthroplasty
* Eligible for combined spinal-epidural anesthesia and postoperative epidural analgesia
* Able to understand and use patient-controlled epidural analgesia
* Provided written informed consent
Exclusion Criteria:
* Refusal to participate in the study
* Known allergy or hypersensitivity to study medications
* Body mass index (BMI) ≥ 40 kg/m²
* Body weight \< 40 kg
* Severe cardiac disease, including symptomatic arrhythmia or advanced conduction abnormalities
* Coagulopathy (INR \> 1.5 or platelet count \< 100,000/mm³)
* Pregnancy or breastfeeding
* Revision total knee arthroplasty or emergency surgery
* Active infection at the site of regional anesthesia
* Chronic opioid use or opioid dependence
* Neurological disease or preexisting motor/sensory deficit in the lower extremities
* ASA physical status IV or V
* Requirement for intraoperative epidural local anesthetic supplementation due to inadequate spinal anesthesia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total epidural local anesthetic consumption during the first 24 postoperative hours
Timeframe: From initiation of postoperative epidural analgesia in the post-anesthesia care unit (PACU) to postoperative 24 hours